Active Cancer Studies by Approval Date For additional information on any one of these studies contact the Lancaster General Cancer Center

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Megan Waters
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1 Active Cancer Studies by Approval Date For additional information on any one of these studies contact the Lancaster General Cancer Center PROTOCOL NO STUDY TITLE PRINCIPAL INVESTIGATOR ECOG 4508 Three-Arm Randomized Phase II Study of Carboplatin and Paclitaxel in Combination with Cetuximab, IMC-A12 or both for Advanced Non-Small Cell Lung Cancer Patients who will not Receive Bevacizumab-Based Therapy Oyer MD, Randall A 1/12/2010 ECOG 1508 A Randomized Phase II Study of Cisplatin and Etoposide in Combination with either Hedgehog Inhibitor GD-0449 or IGF-IR MoAB IMC-A12 for Patients with Extensive Stage Small Cell Lung Cancer Oyer MD, Randall A 11/10/2009 Retrospective and Prospective Data Collection of Patients with Breast Cancer Treated with MammoSite Radiation Therapy Sample MSN, CRNP, Susan 8/10/2009 ECOG 2905 Randomized Phase 3 Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid ) Alone and in Combination with Epoetin Alfa (Procrit ) in Subjects with Low-or Intermediate-1 Risk Myelodysplastic Syndrome (MDS) and Symptomatic Anemia 6/9/2009 AVF4349n An Observational Study of Treatment Patterns and Safety Outcomes for Metastatic or Locally Recurrent Breast Cancer 9/29/ Identification and Analysis of Families with Genetic Susceptibility to Cancer 9/9/2008 ECOG 2804 The BeST Trial: A Randomized Phase II Study of VEGF, RAF Kinase, mtor Combination Targeted Therapy (CTT) with Bevacizumab, Sorafenib, Temsirolimus in Advanced Renal Cell Carcinoma 8/12/2008 SWOG 0777 NSABP R-04 E2Z04 A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC ) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341,NSC ), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma Without an Intent for Immediate Autologous Stem Cell Transplant A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum Quality of Life in Younger Cancer Survivors 8/12/2008 6/10/2008 NSABP B-42 A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (Al) or Tamoxifen Followed by an Al in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer PrECOG0501 A Randomized Phase II Study Evaluating Vandetanib (ZD6474) in Combination with Docetaxel and Carboplatin + Placebo or Maintenance Therapy with Vandetanib in Patients with IIIb, IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Tuesday, February 09, 2010 Page 1 of 5

2 A Worldwide, Observational Registry Collecting Longitudinal Data on the Management of Chronic Myelogenous Leukemia (CML) Patients (The WORLD CML Registry) in Routine Practice 4/16/2008 ECOG 1A05 ECOG 5103 Randomized Phase III Trial of Consolidation Therapy with Bortezomib (Velcade )-Lenalidomide (Revlimid )- Dexamethasone (VRD) versus Bortezomib (Velcade )-Dexamethasone (VD) for Patients with Multiple Myeloma Who Have Completed a Dexamethasone Based Induction Regimen A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer 12/11/ /11/2007 ECOG-PACCT-1 PACCT-1 Program for the Assessment of Clinical Cancer Tests: Trial Assigning IndividuaLized Options for Treatment: The TAILORx Trial; For Women with Surgically Resected, ER and/or PR + Breast Cancer 8/8/2006 ECOG 2805 ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma 7/11/2006 CALGB ECOG 5202 A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), or with the Combination of Bevacizumab and Cetuximab for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers 12/13/ /13/2005 Severe Neutropenia International Registry Protocol O'Connor MD, G.Thomas 9/28/2005 ECOG 1697 Phase III Randomized Study of Four Weeks High Dose IFN-a2b in Stage T 2bN0, T3a-b -T4a-bN0, and T 1-4, N1a, 2a, (microscopic) Melanoma 9/13/2005 E4A03 Randomized Phase III Study of CC-5013 plus Dexamethasone versus CC-5013 plus Low Dose Dexamethasone in Multiple Myeloma with Thalidomide plus Dexamethasone Salvage Therapy for Non-Responders 6/21/2005 CALGB ACOSOG/Z9001 A Phase III Study of Daunorubicin and Cytarabine Plus or Minus G3139 (Genasense, Oblimersen Sodium, NSC #683428, IND #58842), BCL2 Antisense Oligodeoxynucleotide, in Previously Untreated Patients with Acute Myeloid Leukemia (AML) or Greater than or Equal to 60 Years of Age. Phase III randomized double-blind study of adjuvant ST1571 (Gleevec) versus placebo in patients following the resection of primary gastrointestinal stromal tumor (GIST). 1/18/ /16/2004 NSABP B-38 Phase III Adjuvant Trial Comparing 3 Chemotherapy Regimens in Women with Node-Positive Breast Cancer-- Docetaxel, Doxorubicin, and Cytoxan (TAC) versus Dose-Dense (DD) Doxorubicin and Cytoxan, Followed by DD Paclitaxel (DDAC, Followed by Taxol) versus DD Doxorubicin and Cytoxan, Followed by DD Paclitaxel Plus Gemcitabine (DDAC, Followed by PG). 11/16/2004 Tuesday, February 09, 2010 Page 2 of 5

3 SWOG S0106 Ancillary Studies S9910, S9007 ECOG E-4402 A Phase III study of the addition of Gemtuzumab Ozogamicin (Mylotarg) during induction therapy versus standard induction with Daunomycin and Cytosine Arabinoside, followed by consolidation and subsequent randomization to post- consolidation therapy with Gemtuzumab Ozogamicin (Mylotarg) or no additional therapy for patients under age 61 with previously untreated De Novo acute myeloid leukemia (AML). A randomized, Phase III trial comparing two different rituximab dosing regimens for patients with low-tumorburden, indolent non-hodgkin's lymphoma. 9/21/2004 7/20/2004 S0226 Phase III Randomized Trial of Anastrozole vs. Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women with Metastatic Breast Cancer 6/15/2004 SWOG-S0124 A randomized Phase III trial of Cisplatin and Irinotecan versus Cisplatin and Etoposide in patients with extensive stage small cell lung cancer. 5/18/2004 SWOG-S9925 Lung cancer specimen repository protocol, ancillary for S0124 5/18/2004 NCCTG N0147 A Randomized, Phase III Trial of Irinotecan (CPT-11) and/or Oxaliplatin (OXAL) Plus 5 Fluorouracil/Leucovorin (CF) with or without Cetuximab (C225) after Curative Resection for Patients with Stage III Colon Cancer. 4/20/2004 CALGB A Phase III trial of irinotecan/5-fu/leucovorin or oxaliplatin/5-fu/leucovorin with or without cetuximab for patients with untreated metastatic adenocarcinoma of the colon or rectum. IBCSG NCIC CTG # MA27 Suppression of Ovarian Function Trial (SOFT), A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine-Responsive Breast Cancer. A randomized Phase III of exemestane versus anastrozole in postmenopausal women with receptor-positive breast primary cancer. CALGB A Randomized Phase III trial of Interferon ALFA-2B or Interferon AlFA-2B Plus Bevacizumab in Patients with Advanced Renal Carcinoma. 1/20/2004 NCIC BR.19 A Phase III Prospective Randomized, Double-blind, Placebo Controlled Trial of Epidermal Growth Factor Receptor Antagonist, ZD 1839 (IRESSA) in Completely Resected Primary Stage IB, II, & IIIA Non-Small Cell Lung Cancer 11/18/2002 NSABP B-33 A Randomized, Placebo-Controlled, Double Blind Trial Evaluating the Effect of Exemestane in Clinical Stage TI-3NO- 1M0 Postmenopausal Breast Cancer Patients Completing at Least Five Years of Tamoxifen Therapy 10/21/2002 CALBG Cyclophosphamide and Doxorubicin (CA X 4 Cycles) Versus Paclitaxel (4 Cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A Phase III Randomized Study 8/26/2002 Tuesday, February 09, 2010 Page 3 of 5

4 NSABP-30 SWOG SELECT A Three-Arm Randomized Trial to Compare Adjuvant Adriamycin and Cyclophosphamide Followed by Taxotere (AC6T); Adriamycin and Taxotere (AT); and Adriamycin, Taxotere, & Cyclophosphamide (ATC) in Breast Cancer Patients with Positive Lymph Nodes. A phase III Selenium and Vitamin E Prostate Cancer PreventionTrial. 5/22/2002 1/15/2001 ECOG C89803 A Phase III intragroup trial of Irinotecan plus Fluorouracil/ Leucovorin (5-FU/LV) vs. Fluorouracil/Leucovorin alone after curative resection for patients with Stage III colon cancer. 11/1/2000 ECOG N9831 ECOG 3598 A Phase III Study of Doxorubicin-Cyclophosphamide Therapy Followed by Weekly Paclitaxel With or Without Trastuzumab as Adjuvant Treatment for Women With HER-2 Overexpressing or Amplified Node Positive or High Risk Node Negative Breast Cancer A Phase III Trial of Carboplatin, Paclitaxel, and Thoracic Radiotherapy With or Without Thalidomide in Patients With Stage III NSCLC 9/18/2000 4/17/2000 ECOG 1199 A Phase III study of Doxorubicin-Cyclophosphamide therapy, followed by Paclitaxel or Docetaxel given weekly or every 3 weeks in patients with axillary-node-positive or high risk node-negative breast cancer. 12/1/1999 NSABP P-2 STAR Trial Study of Tamoxifen and Raloxifene for the Prevention of Breast Cancer 4/21/1999 NCIC CTG JMA 17 A Phase III, randomized, double-blind study of Letrozole versus placebo in women with primary breast cancer completed five or more years of adjuvant treatment. 11/18/1998 ECOG 2197 A Phase III study of Adriamycin and Taxotere versus Adriamycin and Cytoxan for the adjuvant treatment of nodepositive or high risk node-negative breast cancer patients. 9/1/1998 ECOG C9581 A Phase III Randomized Study of Adjuvant Immunotherapy with Monoclonal Antibody 17-1A (MoAb17-1A) Vs. No Adjuvant Therapy Following Resection for Stage II (Modified Astler-Collar B2) Adenocarcinoma of the Colon 4/15/1998 ECOG 4494 A Phase III Trial of CHOP vs. CHOP plus Chimeric Anti-CD20 Monoclonal Antibody in Older Patients with Diffuse Mixed, Diffuse Large Cell, & Immunoblastic Large Cell Histologically Non-Hodgkin s Lymphoma 2/1/1998 ECOG C9741 Phase III sequential chemotherapy using doxorubicin, Taxol, and Cytoxan or concurrent doxorubicin and Cytoxan, followed by Taxol at 14- and 21-day intervals for node-positive breast cancer. 1/19/1998 PBT-3 A Phase II Trial of High-Dose Chemotherapy with Cytoxan, Thiotepa, & Carboplatin & Peripheral Stem Cell Support with Women with Locally Advanced inoperable Inflammatory Breast Cancer who were Responding to Induction Chemotherapy 4/1/1995 Tuesday, February 09, 2010 Page 4 of 5

5 ECOG 9344 Doxorubicin dose escalation with or without Taxol as part of the Cyclophosphamide-Adriamycin adjuvant chemotherapy regimen for node-positive breast cancer, a Phase III intragroup study. 1/1/1995 Tuesday, February 09, 2010 Page 5 of 5

CancerPACT Cancer Patients Alliance for Clinical Trials

TM CancerPACT Cancer Patients Alliance for Clinical Trials Listing of Ongoing Cancer Clinical Trials in the Salinas Valley Winter 2008 I. Solid Tumors 1. Breast p.1 2. Central Nervous System p.2 3. Gastrointestinal